Portable Health Files Improve Quality of Care and Health Outcomes: a Randomized Controlled Trial (PHF-RCT)

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2011 by St George Hospital, Australia
Sponsor:
Collaborators:
South Eastern Area Health Service
The University of New South Wales
National Health and Medical Research Council, Australia
Information provided by (Responsible Party):
Marissa Lassere, St George Hospital, Australia
ClinicalTrials.gov Identifier:
NCT01082978
First received: March 8, 2010
Last updated: December 5, 2011
Last verified: December 2011
  Purpose

The PHF trial will assess the acceptability and long term outcomes resulting from the usage of electronic (carried by the patient on a USB memory device) and paper portable health files in a population with high intensity use of medical services. The rationale is that use of the portable health files provides a conduit of direct communication among health care providers of a patient's important health care information and this leads to better care and patient outcomes.

Primary hypothesis: Addition of a patient-held portable health file (PHF) to usual care improves patient outcome and quality-of-life compared to usual care alone.

Secondary hypothesis: Addition of patient-held portable health file (PHF) to usual care is acceptable and satisfactory to patients and their health care providers.


Condition Intervention Phase
Chronic Medical Conditions
Personal Health Records
Electronic Medical Record
Device: Electronic (USB) Portable Health File
Device: Paper Portable Health File
Phase 3

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Health Services Research
Official Title: A Randomized Controlled Trial of Portable Electronic(USB)and Paper Medical Records as an Adjunct to Usual Care (Portable Health File RCT): an Evaluation of Short Term Quality Measures and Long-term Clinical Outcomes

Resource links provided by NLM:


Further study details as provided by St George Hospital, Australia:

Primary Outcome Measures:
  • Combined endpoint of deaths, hospitalisations (excepting day only hospitalisations), and serious out-of-hospital events [ Time Frame: 48 months + 36 month extension ] [ Designated as safety issue: No ]

    The primary outcome is the total number of important clinical events (all hospitalisations except same-day hospitalisations, all serious out-of-hospital events and deaths).

    See above: The assigned treatment (i.e., the e-PHF or p-PHF) will be used for 4 years total. Patients will also be followed for an additional 3 years beyond the conclusion of the randomised trial to see if there are any longer-term lag effects.



Secondary Outcome Measures:
  • Quality of Life [ Time Frame: every 12 months for 48 months ] [ Designated as safety issue: No ]
  • health service utilisation and health care costs [ Time Frame: every 12 months for 48 months ] [ Designated as safety issue: No ]
  • medication errors, duplicative investigations [ Time Frame: every 12 months for 48 months ] [ Designated as safety issue: No ]
  • clinical workflow [ Time Frame: every 6 months for 2 years then every 12 months until 48 months ] [ Designated as safety issue: No ]
  • subject and health care provider acceptability and satisfaction with portable health files (PHF) [ Time Frame: every 3 months for 12 months then every 6 months 24 months then every 12 months until 48 months ] [ Designated as safety issue: Yes ]
  • guidelines uptake and documentation [ Time Frame: every 6 months for 24 months then every 12 months until 48 months ] [ Designated as safety issue: No ]
  • health literacy [ Time Frame: every 12 months until 48 months ] [ Designated as safety issue: No ]
  • information technology and computer expertise [ Time Frame: every 6 months for 24 months then every 12 months until 48 months ] [ Designated as safety issue: No ]
  • adverse events [ Time Frame: every 3 months for 24 months then every 6 months until 48 months ] [ Designated as safety issue: Yes ]

Estimated Enrollment: 750
Study Start Date: March 2010
Estimated Study Completion Date: March 2018
Estimated Primary Completion Date: March 2015 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Electronic (USB) Portable Health File
Patients randomized to this arm of the trial will be given a USB memory device that contains the Portable Health File (PHF) software. The portable health files contained core medical data which functions as a subset of a comprehensive medical record. The portable health file is updated by the health care provider at each visit and could also be updated by patient between visits if necessary.
Device: Electronic (USB) Portable Health File
Patients randomized to this arm of the trial will be given a USB memory device that contains the Portable Health File (PHF) software. The portable health files contained core medical data which functions as a subset of a comprehensive medical record. The portable health file is updated by the health care provider at each visit and could also be updated by patient between visits if necessary.
Other Names:
  • Electronic Personal Health Record
  • Electronic Patient-Health Provider Shared Medical Record
  • Electronic Patient-Health Provider Shared Journal
  • Electronic Patient-carried Shared Medical Record
  • Electronic Patient-carried Continuity of Care Record
Experimental: Paper Portable Health File
Patients randomized to this arm of the trial will be given the paper Portable Health File. The paper Portable Health File contains core medical and other important data which functions as a subset of a more comprehensive medical record. This paper-based portable health file is updated by health care providers at each visit. The PHF can also be updated by patient between visits.
Device: Paper Portable Health File
Patients randomized to this arm of the trial will be given the paper Portable Health File. The paper Portable Health File contains core medical and other important data which functions as a subset of a more comprehensive medical record. This paper-based portable health file is updated by health care providers at each visit. The PHF can also be updated by patient between visits.
Other Names:
  • Paper Personal Health Record
  • Paper Patient-Health Provider Shared Medical Record
  • Paper Patient-Health Provider Shared Journal
  • Paper Patient-carried Shared Medical Record
  • Paper Patient-carried Continuity of Care Record
No Intervention: Usual standard of care
Patients randomized to this arm of the trial will not be given a Portable Health File. This arm is the concurrent control comparator arm.

Detailed Description:

A common problem faced by patients and clinicians in our health system is continuity of care and 'clinical handovers'. Few medical record technologies, paper or electronic, top down or bottom up, have been evaluated in a randomised clinical outcome trial to determine the clinical benefits and costs of 'shared' medical and health information. Furthermore, although there are many studies that have evaluated processes of care only a minority do so within a randomized design. Given that any difference is, possibly, small to moderate in magnitude, and given confounders, the use of a randomisation is an essential design requirement.

The first 12 months of the trial constitutes Stage 1 whose primary objective is to describe the acceptability and satisfaction of the our Portable Health Files, and other key process measures. The subsequent 36 months constitutes Stage 2 whose primary objective it to compare important clinical outcomes. The assigned treatment (i.e., the e-PHF or p-PHF) will be used for 4 years total.

To take into account a probable lag effect of the interventions, patients will also be followed for an additional 3 years beyond the conclusion of the randomised trial to see if there are any longer-term effects.

The trial is un-blinded so there will be a potential for bias in trial conduct and a potential for ascertainment bias in the determination of important clinical outcomes and quality-of-life. To reduce clinical outcome ascertainment bias a blinded Adjudication Committee will make the determination which out-of-hospital events are "serious". The other primary outcomes: mortality and all overnight hospitalizations are objective outcomes and are not subject to ascertainment bias.

Secondary outcomes include quality of life, quality measures uptake, investigations, medication use, medication errors, and adverse drug reactions. Utilities and costs will also be collected for cost-effectiveness analysis. Patient and provider acceptability and satisfaction with the PHFs will be also collected.

All primary analyses will be undertaken masked to randomized arm allocation.

Most secondary analyses including quality of life, quality measures uptake, investigations, medication use, medication errors, and adverse drug reactions, health utilities, health care utilisation and health care costs will also be undertaken masked to randomized arm allocation.

This Adjudication Committee will also monitor trial safety and scientific integrity.

  Eligibility

Ages Eligible for Study:   60 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Subjects must be of age 60 or greater
  2. Patients living independently in the community. Hostel care is acceptable, but patients that are not independent requiring full nursing home care are excluded.
  3. Subjects must have had six medical practitioner visits in the previous 12 months
  4. Subjects must have at least two of the following confirmed chronic diseases that require prescription oral or parenteral drug treatment or surgery and requiring at least annual specialist consultation: cardiovascular, respiratory, endocrine, renal, neurologic, gastrointestinal, hepatic, genitourinary, haematologic. infective, rheumatic, inflammatory, immunologic or neoplastic disease.

6. Subject's GP must have access to a computer during the consultation visit. 7. Subjects must have at least two medical specialists at least one of whom has access to a computer during the consultation visit.

8. Subjects must be able to understand the purpose of the trial and undergo full and valid informed consent.

Exclusion Criteria:

  1. Life expectancy of less than 12 months.
  2. Inability to carry a paper PHF or e-PHF and having no care-giver willing and able to accomplish same.
  3. Mentally unable to undertake valid informed consent.
  4. Patients who are not independent in the community, that cannot mobilise to see a specialist or requiring full nursing home care
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT01082978

Contacts
Contact: Marissa ND Lassere, MBBS PhD +61 291132139 marissa.lassere@sesiahs.health.nsw.gov.au
Contact: Sue Baker, BSc +61 291132705 sue.baker@sesiahs.health.nsw.gov.au

Locations
Australia, New South Wales
St George Hospital Recruiting
Kogarah, New South Wales, Australia, 2217
Contact: Marissa ND Lassere, MBBS PhD    +61 2 91132139    marissa.lassere@sesiahs.health.nsw.gov.au   
Contact: Sue Baker, BSc    +61 2 91132705    sue.baker@sesiahs.health.nsw.gov.au   
Principal Investigator: Marissa Lassere, Professor         
Sponsors and Collaborators
St George Hospital, Australia
South Eastern Area Health Service
The University of New South Wales
National Health and Medical Research Council, Australia
Investigators
Study Chair: Marissa ND Lassere, MBBS PhD St George Hospital and Univeristy of NSW
Principal Investigator: Kent R Johnson, MD Newcastle University
Principal Investigator: George Rubin, MD South East Sydney Area Health Service
Principal Investigator: Anthony Sara, MBBS MBA South East Sydney Area Health Service
Principal Investigator: Andrew Parle, BSc (Hons) PhD Consultant
Principal Investigator: Vincent McCauley, MBBS PhD Central Queensland University
  More Information

No publications provided

Responsible Party: Marissa Lassere, Senior Staff Specialist, St George Hospital, Australia
ClinicalTrials.gov Identifier: NCT01082978     History of Changes
Other Study ID Numbers: PHF-06-124-ML, NHMRC 455467
Study First Received: March 8, 2010
Last Updated: December 5, 2011
Health Authority: Australia: National Health and Medical Research Council
Australia: Human Research Ethics Committee

Keywords provided by St George Hospital, Australia:
Quality of Life
Health Care Quality and Safety
Randomized controlled trial

ClinicalTrials.gov processed this record on September 22, 2014